Columbia University Human Research Protection Program

Information for Research Subjects

Research at Columbia University

Columbia University is one of the top research institutions in the world. Thousands
of studies are conducted by the university's faculty and research staff each year. Much
of this research has led to important results that help us lead healthier and better lives.

There are a wide range of areas where research can take place. These areas include research
on health and medical issues, and research on ways of learning, and answers to person and social problems.

What is Research?
Research can be described as an investigation of an issue to learn more about it. It is usually funded by
the government, private foundations, and/or drug companies with the hope that the new information will be
useful to the public and to other researchers.

Some research can only be done with human participants. Until the medicine or equipment is proven to
be useful for people, it cannot be approved by the government for medical use. Not all research conducted
at Columbia University is medical. Some researchers focus on issues related to human behavior or learning
and others investigate complex social issues.

What is Clinical Research?
Much of the research that involves people is conducted by medical doctors, nurses, dentists, social workers,
and other health professionals. Their work to find new medicines and treatments is called clinical research.

Some Examples of Research Involving People Are:

Developing a new test for breast cancer.

Finding the best ways to reduce child abuse.

Comparing two drugs for the treatment of heart disease to see which one works better

Developing the best ways to reduce racial and religious intolerance.

Developing lenses to help people see more clearly after eye surgery.

If you have any questions about your rights as a participant in a research study, you may contact:

What About Research With Children?
It is important that children, as well as adults, be involved in research so that scientists can understand
more about the health and behavior of children. The laws and regulations that apply to all research have
special rules to protect children. Children under 18 years of age cannot agree to participate in research
for themselves.

Parents and/or guardians who are thinking about having their child involved in research are encouraged to
talk with the researchers and to ask them as many questions as they may have.

What is Informed Consent?
Informed consent is a process. People who agree to participate in research must first understand and agree
to volunteer based on the information provided to them by the researcher. That information must include
details about the research, how long it will last, how many visits it will take, and all the risks and
benefits.

The Informed Consent Form must contain the names and phone numbers of the researchers and of the Institutional
Review Board so that the participant can ask questions about the research or report any problems.

What is the IRB?

Research in which people will be asked to participate cannot begin until it has been approved by an Institutional
Review Board (IRB). This group of people often includes doctors, social workers, nurses, scientists, and people
from the local community. They all work together to make sure that human research is well planned and ethical.

The IRB decides, when approving studies, that it is reasonable to ask people whether they want to be involved.
Both before and during the research study, the IRB serves to protect the rights and welfare of research participants.
It makes sure that any risks in the research study are as small as possible. The IRB also reviews each study while
it is going on to make sure volunteers continue to be protected.

Should I Participate in Research?

Why Volunteer for a Research Study?
People have many different reasons for volunteering for a research study. Some of those reasons are to:

Help find a cure for an illness.

Help find ways to provide better care for sick people.

Help gather information about how people think and behave.

Help discover more about how the body and mind work together.

Take part in a study with the hope that they themselves will get well or better. (There is no guarantee,
though, that this will happen.)

What Questions Should I Consider Before Agreeing to Take Part in a Research Study?

What could happen to me, good and bad, if I take part in the research?

What tests or procedures will be done?

Is it possible that I will receive a placebo?

Could my condition get worse during the study?

What will happen if it does?

What other choices do I have if I decide not to be in this study?

If I am injured or suffer an illness because I'm in a study, who will pay the costs that may result?

Who will pay for any extra costs related to the study?

Will I be charges anything or be paid to be in this study?

If I decide to take part, how will this study affect my daily life?

Who will be in charge of my care? Will I be able to continue to see my own doctor?